NCT02328066

Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion

Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion in Colon Lesions. Prospective Multicenter Study in Routine Clinical Practice

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,171 (actual)
• Sponsor: Asociación Española de Gastroenterología · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the diagnostic accuracy of NICE classification to predict deep submucosal invasion of colonic polyps \> 1 cm, considering histology as the gold standard, in a group of endoscopists who previously performed a training program.

Detailed description

In the first phase of the study, a learning program of NICE classification based on examples will be performed. Forty images will be evaluated before and after the learning program. In the second phase of the study, all consecutive patients who underwent to a colonoscopy will be included if a lesion greater than 1 cm is found and the endoscopy is performed with a high definition colonoscope with Narrow Band Imaging (NBI). Patients, lesions and endoscopy equipment characteristics will be recorded. Subsequently, histological diagnosis of the lesion will also be recorded. Evaluated test (NICE classification) was blinded to the pathologist who performed the gold standard test (histology). In case of adenocarcinomas, histological predictors of lymph node metastases, with predefined assessment criteria, will also be recorded. Finally, histological preparations of adenocarcinomas will be sent to the reference center and two experienced pathologists will examine them again.

Conditions

• Colonic Polyps

Interventions

Type	Name	Description
DEVICE	NBI used by trained endoscopists	Examination of colon lesions, using NBI and NICE classification, by endoscopists who previously performed an easy learning program. The learning program consists on the reading of two reference articles and a tutorial explaining the NICE classification. This tutorial shows several lesions and describes the characteristic features in which the classifications focus on.

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2014-12-31
• Last updated: 2018-06-27

Locations

1 site across 1 country: Spain